Frailty in Vascular Patients Undergoing Surgery

NCT03668821 | Unknown

• 1 other identifier: 18HH4445
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.

Conditions

Vascular Diseases; Carotid Artery Diseases; Aneurysmal Disease; Peripheral Artery Disease

Keywords

Vascular Diseases; Peripheral Artery Disease

Outcome Measures

Primary Outcomes (4)

• Correlation between electronic Frailty Index and survival and complication rate.

  Survival and rate of complication correlated with the pre-operative frailty score (electronic Frailty Index).

  6 months

• Correlation between Q Mortality Index and survival and complication rate.

  Survival and rate of complication correlated with the pre-operative frailty score (Q Mortality Index).

  6 months

• Correlation between ACS Risk Calculator Score and survival and complication rate.

  Survival and rate of complication correlated with the pre-operative frailty score (ACS Risk Calculator).

  6 months

• Correlation between V-Possum and survival and complication rate.

  Survival and rate of complication correlated with the pre-operative frailty score (V-Possum).

  6 months

Secondary Outcomes (2)

• Activity Levels Pre and Post Surgery as measured by the General Practice Physical Activity Questionnaire

  6 months

• Quality of Life Pre and Post Surgery as measure by the EuroQoL EQ-5D questionnaire

  6 months

Study Arms (3)

Carotid Artery Disease

Patients with Carotid Artery Disease. Quality of life and frailty questionnaires

Other: Questionnaire

Aneurysmal Disease

Patients with Aneurysmal Disease. Quality of life and frailty questionnaires

Other: Questionnaire

Peripheral Artery Disease

Patients with Peripheral Artery Disease. Quality of life and frailty questionnaires

Other: Questionnaire

Interventions

Questionnaire OTHER

Quality of life and frailty questionnaires

Aneurysmal Disease; Carotid Artery Disease; Peripheral Artery Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients attending Vascular Surgery department for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation.

You may qualify if:

• All patients attending for aortic aneurysm repair, carotid artery surgery and lower limb revascularisation under the care of the Vascular Surgery team
• Willing and able to give informed written consent

You may not qualify if:

• Those unable to give informed written consent
• Those \<18 years of age
• In the opinion of the investigator unable or unwilling to comply with the requirements of the study

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (2)

Imperial College London

London, W6 8RF, United Kingdom

NOT YET RECRUITING

Imperial College Healthcare NHS Trust

London, W68RF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vascular Diseases; Carotid Artery Diseases; Peripheral Arterial Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alun H Davies, DM FRCS

  Imperial College London

  STUDY CHAIR

Central Study Contacts

Tristan R Lane, PhD FRCS

CONTACT

02033117317; tristan.lane@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 13, 2018
• Study Start: January 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 3 years for 5 years
• Access Criteria: Health researcher for non-commerical research

Locations

GB (2)